Waukon native Dr. Michael Osterholm shares his views on recent reports on the effectiveness of vaccines

by David Johnson

The cruel winter cold crushing memories of summer’s warmth added to those first snowflakes burying the season’s fallen leaves are always good indicators that something new is replacing something old. But with this change of the times are those creeping coughs and sneezes that were lurking, waiting to make an appearance and later to be announced as the beginning of the cold and flu season. The common cold is tolerated but what is dreaded is that onslaught of the flu, sometimes mild but usually hitting like a hammer on your health and well-being.
Unlike the cure for the common cold, there are some remedies available to fight influenza. What is recommended by health professionals is a vaccination with the available influenza vaccine at the beginning of the flu season, usually in September and October. Every year there is offered a vaccine for the projected influenza, a vaccine that is tweaked in make-up from last year’s vaccine but always is different from previous offerings.
But how effective is this vaccination? Is it worth it? Does it prevent or at least control the bad effects of influenza? Are the vaccines for the “pandemic” influenzas effective on the seasonal influenza? Many of these questions have been answered after a recent study that was released in October of 2011.
A research study, led by Waukon native Dr. Michael Osterholm of the University of Minnesota and the lead scientist and head of the university’s Center for Infectious Disease Research and Policy, produced evidence on how effective flu vaccines are based on studies of the last 40 years. After examining hundreds of studies and articles, the most recently released research included only 31 eligible studies. The research that narrowed its parameters to those studies that utilized laboratory-confirmed or culture-confirmed influenza blood tests were considered not conclusive and ineffective for determining the effectiveness of flu vaccines. The blood tests checked to see whether there were elevated levels of flu antibodies in the blood instead of determining whether an influenza virus was present.
What was learned was that two vaccines - the trivalent inactivated vaccine (TIV) and the live attenuated influenza vaccine (LAIV) - which account for 99 percent of this country’s vaccines, are less effective than previously believed. The TIV vaccine is the traditional shot in the arm and the LAIV vaccine is the nasal spray now available. It was generally felt by those in the medical community that the flu vaccines were 70 to 90 percent effective, but what was discovered was “that there are a number of differences in how influenza vaccines performed in different populations of the people”, as stated by Dr. Osterholm.
After the study was released, the media headlined that flu vaccines are only 59 percent effective, something that Osterholm claims is not entirely true when taking into account the full disclosure of the results. “This study shows that there is no traditional one-number answer,” adds Osterholm.
According to the report, randomized controlled trials of TIV vaccine, which is given to 90 percent of the nation’s adults receiving flu shots, were effective in preventing influenza in eight of 12 seasons and had a combined efficacy of 59 percent against the flu in healthy adults.
The LAIV was shown to provide protection in nine of 12 seasons against infection and was 83 percent effective combating the flu when given to children aged six months to seven years. For LAIV, there was no data showing efficacy for people aged eight to 59 years.
There were no randomized controlled trials of TIV for children two to 17 years of age meeting the study inclusion criteria. One study assessing TIV vaccine efficacy in children age six months to two years was done over two seasons with good matches between vaccine and circulating virus strains in both years. There were no studies of TIV and one study of LAIV showing protection for those 60 years of age and older. The study feels that this information gap needs to be addressed.
The median effectiveness of the monovalent pandemic vaccine was 69 percent against medically-attended pH1N1 influenza in people aged less than 65 years of age. Dr. Osterholm pointed out that in Europe, where adjuvants are used in the vaccine, the success rate is 63 percent, whereas in the United States, where adjuvants are not used, it is 56 percent effective in young healthy adults.
Presently, there are four vaccine options: the traditional shot in the arm, a nasal spray, a high-dose vaccine for older adults and Sanofi’s newly-launched Fluzone Intradermal vaccine, which uses a short needle and delivers the vaccine into the skin rather than the muscle. Flu vaccinations protect against three types of influenza viruses and cannot give you the flu because they don’t contain live influenza viruses. The purpose of the vaccination is to protect against the possibility of serious illness or even death from the flu.
Even if the vaccine is less effective than earlier thought, it is better than no flu shot, which is 0% effective. One study found that the flu shots reduce hospitalizations by eight percent. When considering the flu hospitalizes about 200,000 people a year, a flu shot should be an important factor during each influenza season.
Additional to a flu shot, there are other factors to implement. Taking simple steps like washing your hands, covering your coughs and sneezes with a tissue or your sleeve instead of your hands, and staying home when you are sick are recommended by medical professionals.
Dr. Osterholm is concerned about not only the effectiveness of the seasonal flu vaccines, but the vaccines for the more dangerous pandemic influenzas that can kill millions. The report discovered that a problem exists in the medical community, that it lacked the evidence of how effective the flu shot is for some of the most vulnerable members of society. He feels that agencies such as the Centers for Disease Control (CDC) and other public health agencies should use a “we don’t know” answer, which would be more forthcoming than the patent “it is effective” answer when asked about the effectiveness of the flu vaccine.
If a flu vaccine is not as effective, a narrowed declaration may eventually undermine the credibility of the CDC and other agencies responsible with ascertaining the success of the vaccines. Because the influenza virus mutates so often, scientists change the ingredients of the vaccine from year to year, thus a conclusive answer on effectiveness is not known.
Because of this, health officials are reluctant to state any ineffectiveness for fear that the public will not receive the protection of a flu shot. The conclusion of the report still should not dissuade individuals from getting a flu vaccine. The study was necessary to gauge the effectiveness so a new strategy can be introduced and implemented to improve the overall success of flu vaccines in the future.
Dr. Osterholm stresses that everyone read the last statement of the report, “…We maintain public support for present vaccines that are the best intervention available for seasonal influenza.” Depending on the relative strength of each seasonal influenza outbreak, some three to 50 thousand people die each year in this country and over half a million world-wide. Thus, it is encouraged that everyone receives a vaccine as the vaccine is the best tool to fight the flu.
The report urges that a new generation of more effective flu vaccines is needed. What is recommended is “active partnerships between industry and government needed to accelerate research, reduce regulatory barriers to licensure and support financial models that favor the purchase of vaccines that provide improved protection.” When asked about this statement, Osterholm pointed to the fact that for such a program to be established and a successful vaccine to be produced, it would cost at least one billion dollars to bring about the vaccine. There are six major global drug companies and many smaller independent companies, but none would be willing to undertake such a financial burden unless partnered with government entities.
This University of Minnesota professor feels that once this coalition is established, you will see results in seven years minimum. With scientists working to discover a universal vaccine that is successful to combat the ravages of influenza, society will be much more protected than it is now. Osterholm has been in the forefront in identifying and alerting the public on influenza and feels this report will be instrumental in jump starting a program to develop a successful vaccine, a vaccine needed for some more deadly strains that are emerging world-wide.
He stated that there is emerging another ‘hotspot’ in the world of a possible pandemic influenza. H5N1 flu in Egypt has a 35 percent mortality rate, much more potent than, say, the Spanish flu of 1918 which killed around five percent of those afflicted. In Southeast Asia, there is a strain that has a 75 percent mortality rate but the African strain concerns health officials more as it appears it will transmit more readily from animals to humans then spread from human to human. With a possible spread and worldwide affliction of a killer or pandemic flu, Dr. Osterholm stresses the importance of a ‘21st century’ vaccine to be developed to combat future health threats.
Today, scientists are studying adjuvants (ingredients that when added to the flu shot will stimulate a stronger immune response) to find that right element to provide protection for more people. With possible breakthroughs on different elements such as those being presently studied, it is believed that modern vaccine will be available sooner than later, if there is the recommended cooperation of government, medicine and the drug companies.
At UT Southwestern, Dr. Beatrice Fontoura has discovered a compound that she claims works to fight multiple strains of flu, including strains of the more serious pandemic influenzas. The compound targets a specific protein called REED-1, which is responsible for helping cells fight infection. Dr. Osterholm has examined those findings and research and is somewhat skeptical of the research that supports this recent discovery.
What is encouraging is that there exists a continued research by many groups and individuals to find that protection for humans against the onslaught of influenza in this country. What Dr. Osterholm finds more troubling are the many declarations by individuals, such as Dr. Russell Blaylock and Dr. Wolfgang Wordarg, an epidemiologist and president of the Health Committee of the Council of Europe. These gentlemen and Dr. Mehmet Oz, who announced on CNN that his wife was not going to vaccinate their children with a swine flu vaccine, claim that vaccines such as the pandemic flu vaccine are not safe or the dangers of a pandemic are nothing more than a “great campaign of panic.”
Osterholm points out that numerous health agencies in this country have criticized the Council of Europe, which is not a government institution, with irresponsible statements and positions. Osterholm continued by explaining that there are many individuals who are experts in their particular field who do not have the expertise on the issue debated but who are still given media attention due to their credentials they have been recognized for.
He compares this phenomenon to the global warming argument and individuals involved in this issue. There are individuals who claim there is no global warming who have no expertise in the scientific fields dealing with this perplexing problem but are still given credibility by the public. Osterholm feels that when there is a consensus by experts on an issue, then the consensus on the conclusion of that issue deserves credibility, which has been the opposite on issues like global warming and flu vaccinations.
The recent study completed by Osterholm and his colleagues has received no negative feedback from any of the government agencies, drug companies or those individuals and organizations involved in the fields of medicine concerned with the problem of influenza and remedies for this virus. This silence promotes the validity of the study and sheds a great deal of light on the present status of the flu vaccines and the necessities to begin a more successful program in the future.
When asked what the goal is when combating influenza, Dr. Osterholm replied that his wish is “A vaccine that is 100% effective.” He would like to see a “measles-like vaccine”. In comparison to the flu vaccine, two measles shots prevent about 95% of infections, and polio vaccines have eliminated polio in all but a handful of countries.
If there is a vaccine that is 100% effective, would  mandatory vaccinations be recommended as suggested by some in the media and the government? Osterholm replied that he has seen some evidence that a mandatory program for adults might not be successful but for children it could be considered.
Even with the completion of this study and the publication of the research, in February of 2012 another report is to be issued on the subject. More information is to be released and with that, hopefully, the public will receive an in-depth compilation of information which will shed more light on what can be done or should be done.
Osterholm believes this research on vaccines is not a conclusive “black or white” study but “somewhere in between”. There might not be a cure for the common cold, but if everything falls into place, there could be, if not a cure, a good defense against the flu. Thanks to this recent study, if there is the research and development plus cooperation by governments on regulations with licensing new flu vaccines, the flu may join the ranks of other human afflictions like the mumps, chicken pox and polio - a memory of the distant past.